FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
The National Comprehensive Cancer Network added Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, to the NCCN Clinical Practice Guidelines in Oncology. Lymphir is included based on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that the drug is appropriate as an option for patients with CTCL.
The European Commission approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.
The European Commission approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory follicular lymphoma or r/r diffuse large B-cell lymphoma, after two or more lines of systemic therapy. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
The European Commission approved Imfinzi (durvalumab) and Lynparza (olaparib) as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as first-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient disease. Imfinzi plus chemotherapy followed by Imfinzi alone has been approved for patients with mismatch repair deficient disease.
The European Commission granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of prior therapy. Tepkinly is the only subcutaneous T-cell engaging bispecific antibody approved to treat both r/r FL and r/r diffuse large B-cell lymphoma in the EU, as well as the European Economic Area countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
The National Cancer Institute approved the following clinical research studies last month.
At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).
The University of Texas MD Anderson Cancer Center and collaborators are initiating a research project that will send T cells to the International Space Station to study the effects of prolonged microgravity on cell differentiation, activation, memory, and exhaustion.
The University of Kansas Cancer Center and the University of Kansas Health System received $20 million in new federal investments.
